Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia

Acute Leukemia Clinical Trial

Official title:

Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02677064
• Other study ID #: 16-024
• Status: Recruiting
• Start date: February 2016
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Boglarka Gyurkocza, MD
• Email: ABMTTrials[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.

Description:

Additional Arms have been added for MSK patients only. Patients with MDS and MPN Patients with Post-transplant Relapse of Acute Leukemia, MDS or MPN

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1365
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A

• Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):

• Clinically significant cytopenia of at least 2 cell lines affected; Hgb<10,

• Platelet<100,000, absolute neutrophil count<1000

• Bone marrow blasts >5% and any level of circulating blasts

• Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.

• IPSS Intermediate-1 and higher

• IPSS-R intermediate and higher

• All cases of therapy related MDS with excess blasts

• In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermidiate 1 and higher.

• Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.

• Patients 18 years of age or older and 80 years of age or younger

• For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.

Exclusion Criteria:

• Patients with polycythemia vera (PV) and essential thrombocytosis (ET)

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia
• Newly Diagnosed
• Relapsed

Intervention

Other:
• assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who proceed to transplant	determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center